Reliability, Validity, and Responsiveness of the Turkish Version of Eating Assessment Tool-10 for Patients With Primer Sjögren's Syndrome

NCT06401811 | Recruiting

• 1 other identifier: KSU.
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluations will be made by researchers following the guidance of individuals with primary Sjögren's Syndrome who receive diagnosis, routine medical care, and treatment management. In addition, for the reliability of the Turkish Eating Assessment Tool-10, the Turkish Eating Assessment Tool-10 will be repeated on patients at least one-fifth of the number of individuals included, after one week. For the sensitivity of the scale, an exercise that is routinely applied in the Rheumatological Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation will be invited and after 3 months, the same evaluations as applied in the first measurement will be made again on individuals at least one-fifth of the number of individuals included.

Conditions

Sjogren's Syndrome

Keywords

Primer Sjogren's Syndrome; swallowing disorder

Outcome Measures

Primary Outcomes (1)

• Turkish Eating Assessment Tool

  Turkish Eating Assessment Tool-10 is a survey consisting of 10 questions with a Likert scale between 0 and 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points by finding the sum of the answers given by individuals to each question. A score of 3 or more in the survey is considered abnormal. A score of 16 or above is considered a suspicion of aspiration. Turkish validity and reliability were tested by authors in 2016.

  Baseline-first week-third month

Secondary Outcomes (1)

• Yale Swallow Protocol

  Baseline-third month

Other Outcomes (2)

• Test of Mastication and Swallowing Solids

  Baseline-third month

• Dysphagia limit

  Baseline-third month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with primer Sjogren's Syndrome diagnosed by a rheumatologist.

You may qualify if:

• Patients diagnosed with Primary Sjögren's Syndrome
• years or older

You may not qualify if:

• Patients with Secondary Sjögren's Syndrome,
• Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
• Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome; Deglutition Disorders

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Nazli Elif Nacar, MSc

CONTACT

+903443004085; nelifnacar@ksu.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: June 4, 2024
• Primary Completion: August 30, 2024
• Study Completion: November 30, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

TU (1)